Activities of the Open-Ended Online Forum (2014-2016)

POSTED ON BEHALF OF MARIA MERCEDES ROCA (MODERATOR)

-----

Dear participants of the online forum,

My sincere thanks and appreciation to the Secretariat for inviting me to moderate a follow-up discussion to the one we had in May. The discussion will run for two weeks, commencing on Monday June 13 and finishing on June 29.

Let us please recall that our task was triggered by decision BS-VII/12, in which the COP-MOP mandated the Online Forum and AHTEG to take into account the topics prioritized by the previous AHTEG for the development of further guidance (among which there is a topic on “risk assessment of LMOs developed through synthetic biology”).

During forum 1   (May 9-23), we had a discussion with the purpose of brainstorming to identify issues that could be of particular relevance in the risk assessment of LMOs developed through synthetic biology.

As I mentioned earlier, I am committed to ensuring transparency in this process, so all views will be reflected in the summary of forum 2.

I documented  that many of those who posted in forum 1  were of the view that it is either premature or unnecessary to develop guidance on this topic because of the lack of specific examples of aspects of living modified organisms developed by synthetic biology that are not covered by the Cartagena Protocol, Annex III and existing Guidance. My summary of forum 1 can be found here:  https://bch.cbd.int/forum/ahteg/oeof_ahteg_2014-2016/moderators_summary_synbio.doc?download

I would like to stress that the responsibility to decide whether or not further guidance on RA of LMOs of synthetic biology is needed belongs with the COP-MOP. Our role is to provide the COP-MOP with scientific input to assist the Parties in reaching an informed decision, and the results of our discussion must help guide the outcomes of the COP-MOP.

In my opinion, to achieve our goal while ensuring transparency in the process, it is key that the COP-MOP be properly informed that there are two sides of the debate: the majority sees no benefit from the development of further guidance, but others do. It is also essential that the views from both sides of the debate be supported by arguments grounded on science and not speculation of future scenarios. 

I recognize that some Parties and Observers have concerns or questions regarding policy issues and procedures. I encourage those groups to approach the Secretariat directly to ask for clarification and guidance.

Thus, during the next 2 weeks, I urge you to limit your interventions exclusively to scientific issues and to avoid discussions about policy issues and the process behind this topic. Please note that in order to conclude that there is a need for further guidance on risk assessment for LMOs developed through synthetic biology, there is a need to identify concrete examples of current and foreseeable LMOs that present novel and specific challenges to the general principles and methodology of Annex III.

I also kindly ask you to use the background document for this discussion as a basis for your intervention.  For clarification and transparency, please note that the background document was drafted by the Secretariat. Please make comments and suggestions directly to the document (in track changes), providing scientific arguments to support your views. The background document for this discussion is attached to this message and posted in the page of the discussion. For further reference, I will refer to this as “Doc 1 Secretariat Synbio RARM” : http://bch.cbd.int/onlineconferences/onlineconferences/forum_ra/discussion.shtml)

Please note that, far from summarizing any type of consensus, this document attempts to compile the views of some experts with regard to considerations that would be particularly relevant to the risk assessment of LMOs developed through synthetic biology.

Your task during this discussion is to either support, or not, each of the considerations in the document based on scientific arguments. Identifying concrete examples of current and foreseeable LMOs that present novel and specific challenges to the general principles and methodology of risk assessment will be most helpful. Proposals for revisions to the text are also welcome.

Finally, for ease of reference, I am including a link to the conclusions and recommendations of the Ad Hoc Technical Expert Group on Synthetic Biology, which may be of less familiarity to the participants of this RARM forum. For further reference I will call this “Doc2 AHTEG Synbio”: https://www.cbd.int/doc/meetings/synbio/synbioahteg-2015-01/official/synbioahteg-2015-01-03-en.doc.

In particular, risk assessment is addressed in paragraphs 58 and 59 and in proposal (f) of paragraph 66 “Conclusions and Ways Forward”.

I look forward to reading your views. The discussion is now open!

Best regards to all.
Maria Mercedes

My sincere thanks to Maria Merceder for moderating the second round of discussions.
I was unable to find the link for Doc1 mentioned in the opening post. Could you please help me on that?
Kindly
Paulo Andrade

Dear Paulo, dear all,

The background document for the discussion (Doc 1 as referred to by Maria) is available as an attachment to this message and to Maria's opening message. Doc 2 (report of the AHTEG on synthetic biology is also attached to this message).

However, please note that attachments only work when the posts are seen in the online forum (not via email - my apologies for that; this is something that is in the todo list of improvements of our IT team). To go to the online forum, please click on the link "See this post in the online forum" at the end of the message when reading it via email and you will taken to the online forum where the documents are available as attachments.

Please let me know if you have any difficulty in accessing or opening the files.

Best regards,
Manoela

Dear Colleagues.
In the sake of a profitable discussion, I tried to pinpoint some statements from the AHTEG report on Synbio which are essentially scientific and directly involve risk assessment. My comments and a conclusion can be found below. I will come back later with commnets on the second document, namely Possible considerations during the environmental risk assessment of LMOs developed or created through approaches commonly referred to as “synthetic biology”

Comments on REPORT OF THE AD HOC TECHNICAL EXPERT GROUP ON SYNTHETIC BIOLOGY

Item 26 states: In its deliberations, the Group highlighted several applications… Those applications, the Group noted, may have both positive and negative impacts on biological diversity at different levels, including genes, species and ecosystems.

My comment: To effectively assess such impacts, it is of paramount importance to have examples of synbio products either ready to be evaluated for commercial use or still in some development stage in innovation. Once the examples are available, comments on the applicability of the AHTEG guidelines to assess environmental risks of such products will be of value, but not before. Comments made on general ground are of little value for a meaningful discussion.

Remark: a product is here a living organism and not a chemical product as suggested in item 32 of the same AHTEG report

Item 27 highlights the need for “an appropriate baseline for measuring the potential positive and negative impacts of synthetic biology on each of the objectives of the Convention needs to be considered or developed”.

My comment: In the absence of a candidate product, it is useless to produce a broad baseline triggered by theoretical considerations. Moreover, baselines tend to be very expensive to produce and of limited use as a large amount of variables may confound the results and impair a proper assessment of the specific GM or synbio product impact. Moreover, baselines should not be confounded with comparators, which are usually needed.

Item 29 informs that “some members … noted that there is a potentially higher level of uncertainty due to the increased depth of intervention of synthetic biology in living organisms and biological systems” and emphasize “the need for Governments to take a precautionary approach when addressing threats of significant reduction or loss of biological diversity posed by organisms, components and products resulting from synthetic biology…”

My comment: In the absence of at least a couple of conceivable products derived from synbio it is premature to state either that they will encompass an increased level of intervention or, even if they do so, that this level would lead to higher risks or a higher level of uncertainty. An organism frequently cited as a synbio product, but which was not regarded as such by the Brazilian National Biosafety Agency is the farnesene-producing GM yeast, which contains more than a dozen specific genomic changes. No addition risks or uncertainties derived from the complex biotech solution as the genetics and the general biology of Saccharomyces cerevisiae is very well known and the principles of risk assessment do apply integrally to this GMO.  Indeed, other member of the AHTEG noted that “there are mechanisms built into existing risk assessment frameworks which take into account such uncertainties in a stepwise manner while building on past experience with the existing frameworks” Moreover, they also noted that “the nature of synthetic biology research and development may lead to more predictability in the characteristics of the resulting organism, thereby facilitating the risk assessment process and reducing uncertainty”. I fully agree with this latter opinion, taking into account genome editing and other modern biotechnology resources.

The same comment applies to items 44, 45 59 and others.

My conclusion: In the absence of a clear, consensual definition of what Synbio products are and specially in the absence of examples of synbio products that could be significantly more difficult to assess using the regular LMO ERA procedures than the known LMOs, I see as over precautionary to treat potential synbio products as different from regular LMOs. If, however, potential threats to the environment can be seen for a given synbio product and, having their risks assessed, do point to a significant risk to the environment, the product should be carefully used or simply rejected, exactly on the same way we usually do with regular LMOs. Once a couple of such products are brought to light, it would then be important to compare their risk assessments to those of convenient LMO comparators as to depict eventual challenges in assessment. Moratoria and other similar procedures will not help the regulators, the risk assessors or the developers and will impair the technology, ultimately negatively impacting our society.

Dear Prof. Paulo Paes de Andrade,

I am not a member of the ATHEG on synbio, but I do not agree to your comments:

1) The target we are going to look at is the organisms, components and products derived from synbio, not only the organisms as recommended by SBSTTA20 this April.

2) There are already successful applications of synbio. One famous example is Artemimisin produced via synbio. There is recently a report from the National Academy of Sciences, Engineering, and Medicine of USA on gene drive. This report lists many applications of gene drive, especially the successful case of mosquitoes.

Thank you!

Wei

Dear Paulo, Dear Wei,

Thank you for your comments, but please let me remind you that the objective of this discussion is not to review or discuss the work of the AHTEG on Synthetic Biology. The report of the AHTEG on Synthetic Biology was shared with you for information and ease of reference only.

I kindly ask you to refer to the moderator's opening message (on top of page https://bch.cbd.int/onlineconferences/onlineconferences/forum_ra/discussion.shtml?threadid=7959), where Maria clearly described the task ahead:

---
[excerpt from the moderator’s opening message]

“I also kindly ask you to use the background document for this discussion as a basis for your intervention.  For clarification and transparency, please note that the background document was drafted by the Secretariat. Please make comments and suggestions directly to the document (in track changes), providing scientific arguments to support your views. The background document for this discussion is attached to this message and posted in the page of the discussion. For further reference, I will refer to this as “Doc 1 Secretariat Synbio RARM” : http://bch.cbd.int/onlineconferences/onlineconferences/forum_ra/discussion.shtml)

“Please note that, far from summarizing any type of consensus, this document attempts to compile the views of some experts with regard to considerations that would be particularly relevant to the risk assessment of LMOs developed through synthetic biology.

“Your task during this discussion is to either support, or not, each of the considerations in the document based on scientific arguments. Identifying concrete examples of current and foreseeable LMOs that present novel and specific challenges to the general principles and methodology of risk assessment will be most helpful. Proposals for revisions to the text are also welcome.”
----

Time is limited and it is crucial that we focus during the next 2 week on the task at hand in order to submit to the COP-MOP scientific and technical advice that will assist the Parties in making a decision whether or not guidance on risk assessment of LMOs developed through synthetic biology is needed.

Thank you very much for your continued input to this process. I look forward to your comments.

Best regards,
Manoela

As this round of discussion gets underway, I would like to draw people's attention to a recent article discussing relevant parameters to consider regarding regulation of new biological developments.  This may be helpful in framing some of our thinking.

The distinction between science and policy which our moderator attempts to make is not very absolute, since each realm highly influences the other.  Thus, these "policy" considerations are quite relevant in thinking about the "science."

Hartley, S., Gillund, F., van Hove, L., & Wickson, F. (2016). Essential Features of Responsible Governance of Agricultural Biotechnology. PLoS Biol, 14(5), e1002453

http://journals.plos.org/plosbiology/article?id=10.1371%2Fjournal.pbio.1002453

My best wishes to all,

Phil Bereano

Dear Manoela Miranda, dear Dr. Wei Wei.

My aim was not the re-discuss any document, but to highlight the technical points deserving further discussion. Apologies if I missed the target.

I agree we should discuss every proposed product and see if it fits the various definitions and if we can come to a consensus, since there is no clear delimitation between regular modern biotechnology and synbio. I may have missed to clarify this point.

As to Dr. Wei second point, I commented this product (a farnesene-producing yeast; artemisin is a farnesene) when I discussed the subject in the context of item 29 in may last post, as well as in the previous round of this forum: the microorganism was extensively engineered, but it is not much different from many other engineered yeasts and bacteria. Its risk assessment was conveniently done by the Brazilian CTNBio with no relevant challenges or remaining uncertainties. The product was regarded as a mere engineered yeast, not a synbio product.

I will refrain of making any further comments and will wait to see how the discussion devellops.
Kindly
Paulo

POSTED ON BEHALF OF MARIA MERCEDES ROCA (MODERATOR)

-----

Dear all,

Many thanks for those participants who have already made interventions. To address to Dr. Bereano's fair point, yes:  policy (including procedures) and technical consideration are linked and we should indeed address both. I encourage participants who have concerns with policy and procedures to contact the Secretariat directly. If however some feel that you would like to share your opinions in public, please do so, providing we do advance with our technical task in the allocated time.

For clarity, I summarize and add direct links to the three important documents that we need to consult.

We are required to make comments on the text I named  “Doc1”, but please also consult Doc 2 and Doc 3 (below)

** Doc 1 Secretariat Synbio RARM : background document drafted by the Secretariat,  to assist parties in reaching an informed decision during COP-MOP. You are required to review this text.
http://bch.cbd.int/onlineconferences/onlineconferences/forum_ra/discussion.shtml)


** Doc 2 AHTEG Synbio: Conclusions and recommendations of the Ad Hoc Technical Expert Group on Synthetic Biology.  https://www.cbd.int/doc/meetings/synbio/synbioahteg-2015-01/official/synbioahteg-2015-01-03-en.doc.

** Doc 3. Moderator´s summary of Synthetic Biology RARM - Forum 1

http://bch.cbd.int/forum/ahteg/oeof_ahteg_2014-2016/background_doc_synbio_discussion.doc?download

** Doc 4. Moderator´s summary of Synthetic Biology RARM - Forum 2
To be posted after the forum ends.

Please note that there are some discrepancies in opinion between Doc 1 and Doc 3.

Many thanks and best regards to all.

Maria Mercedes

Dear Manoela, Paulo,

Thanks for the clarification, sorry for the potential distraction by my intervention. I agree to Paulo that most current applications with organisms are similar to what we called modern biotechnology. However, we shall realize that some virus are created/recreated via synbio are different and need much attention.

Let’s focus on the document ‘Doc 1 Secretariat Synbio RARM’, I fell that the second and third last paragraphs on page no.1 are belonged to the summary on the first round online discussion only and can distract our discussion if presented in this document. As the moderator requested we will submit this doc to COP/MOP for their decision, we do not need these paragraphs here and those paragraphs should be deleted to avoid reopening the discussion on policy.

Thank you!

Wei

Dear Maria, Chair, Secretariat and Colleagues

Please let me begin by thanking Maria for accepting the role of moderator.

I have attached the document sent around previously with some comments in track changes. These comments are meant to support my reasons for thinking that syn bio does present novel and specific challenges for risk assessment. In essence, I argue that syn bio creates certain qualitatively different challenges, not just quantitatively different challenges, from various other products of modern biotechnology.

I don't mean to imply that my thinking on the other topics in the document is complete. However, I wanted to post at least these first comments for consideration and reaction from the group.

Best regards
Jack

Mindful of the parameters set forth for this discussion, I nevertheless want to make one more intervention along the lines of my prior posting.

The separation of science from policy and social context is essentially impossible and can actually be harmful by leading to distorted results. It may be useful as an abstract heuristic exercise, but is always perilous when applied to actual socially embedded processes.


In an earlier round of these Expert Consultations, I may have posted this talk I gave at The Kennedy School, Harvard University, September 2000, at the invitation of Calestous Juma (who was the first head of the Cartagena Protocol negotiations); I apologize if this is a duplication for some of you.

**************************

How Risky Is Safe: The Politics of “Sound Science” and the Precautionary Principle

“It is necessary to establish speedy but reliable risk assessment to implement the Precautionary Principle and at the same time take into account consideration of the socio-economic consequences of modern biotechnology . . . .”  German Delegate, CBD COP V, Nairobi, June, 2000

The modern era of risk assessment can be traced back to Chauncey Starr’s 1969 article in Science, but it was not perhaps until 1976, with the publication of William Lowrence’s Of Acceptable Risk, that the subjective elements of the process began to get a forthright treatment.  While Lowrence tried to maintain that “risk” was scientifically objective, his discussion of “safety”—as socially acceptable risk—acknowledged the political nature of the overall context of the evaluation. But it is obvious that even a rigid determination of a clear risk—say of injury from skydiving or of winning the lottery jackpot—cannot, in itself, tell us why only some people will accept the risk and jump from an airplane or buy a ticket.  Nor can it tell us the fractional portion of the population willing to undergo such an action.  
However, we must recognize that risk itself (defined as the probability of a hazard) has subjective elements.  And when we affirm this characteristic of risk, the Precautionary Principle can be seen as an inherent aspect of risk assessment, not something alien.
Thus, the proposition is the subjective nature of risk itself, and perforce of its assessment.
Subjective aspects include:
• The choice of phenomena to research [eg, note that only a small amount of public money is devoted to looking at the environmental risks of GMOs];
• The definition of what is a “hazard” (ie, undesirable) [eg, is the displacement of peasant farmers by agribusiness part of the “modernization processes” or an instance of cultural annihilation?];
• How to actually measure a hazard, especially if it combines different aspects not subject to a single metric [eg, the death of a bee deprives us of both honey and pollination];
• How to account for incomplete knowledge, uncertainty, etc. in the nature/consequences of the hazard as well as its probability;
• Who has the burden of proof of developing the necessary data—the proponent of the technology, the regulatory agency, or consumer/environmental citizen organizations?;
• How to account for the social distribution of risk, since hazards impact different sectors/classes in society differently [Monsanto shares may increase in value while family farmers are driven off the land];
• How to discount future events in light of present actions [will an endangered species be driven to extinction before other recovery efforts might be mounted];
• How to monitor a risk, and how much surveillance is “worth” in both monetary and non-monetary terms [eg, the absence of a law requiring the labeling of GE food is also a decision that monitoring the long-term cumulative effects of eating such products is not very important to the decision-makers]; and
• How to balance risks against “benefits“, since benefits involve all the above factors as well

Despite this reality, the current dominant paradigm still claims that risk assessment is a matter for “sound science” rather than politics or social values; these other messy factors must wait until after risk is assessed when they can come into play as part of “risk management.”  This bifurcation is historically traceable to William Ruckelshaus’ second tenure as head of the US EPA.
Ruckelshaus was brought back into that role as part of the larger Reaganite agenda to role back the “democratic paradigm” of public policy and install a “technocratic” one (in the terminology of David Dickson, a report/editor with Science, Nature, New Scientist). This manoeuvre helped that Administration (and subsequent ones) deflect popular environmental and consumer concerns while calling for endless technical studies, thus delaying substantially any constraints on industry practices (and simultaneously enabling citizen groups to be discredited as anti-rational and selfish, and alienating liberal scientists from those movements to which they otherwise might have given pro bono advice.) “Sound science” thus became a mantra to obscure the exercise of partisan political power. 
Throughout the negotiations over the Biosafety Protocol, the US delegation always challenged those who promoted the Precautionary Principle as being emotional and attacking sound science.  Yet, as a recent lengthy paper sponsored by Consumers International has documented, US law is full of precautionary provisions. There is no evidence whatsoever that they have hindered the application of science to assessing various risks.  We need to undo the false distinction Ruckelshaus originated, and admit that risk assessment itself involves subjective elements and that management decisions occur from the very beginning of the policy assessment.  When we do, we will see that the Precautionary Principle is a logical component of that process, assuring that we fully address issues of the sufficiency of information and assigning responsibility for carrying it out.
As the EU environmental ministers made clear in a meeting with NGOs in Montreal last January, just prior to the final negotiation of the Biosafety Protocol, they are politicians chosen to make political (hence subjective) decisions after science has told us all that it can; their responsibilities should not be sloughed off onto unaccountable scientists in the guise that some mysterious “sound science” itself can tell us the right choices to make.

*******************************
At this point, I wish to submit recent comments made by a US colleague, Dr. Doug Gurian-Sherman which contain some recommendations that are directly about risk assessment science, although some parts are more about risk policy.


Invited Comments to the National Research Council Committee on “Future Biotechnology Products and Opportunities to Enhance the Capabilities of the Biotechnology Regulatory System” By Doug Gurian-Sherman, Ph.D. Senior Scientist and Director of Sustainable Agriculture, Center for Food Safety
http://www.centerforfoodsafety.org/files/cfs_nrc-invited-presentation_doug-gurian-sherman_june-2_final_2016_80906.pdf

Although these comments are aimed at US regulations, the issues laid out are relevant internationally.  I draw the attention of my colleagues to his discussions of:

“ . . . several of the main challenges for the future, including for organisms developed through new engineering technologies. Important lessons can be learned from current experience with genetically engineered (GE) crops and their regulations. “

“Much of the focus of current risk assessment is on what I will call direct risk, while less direct or indirect risks at the system level are usually ignored, even though they may be more far reaching.”

“But the assessment of the benefits of genetic engineering and other technologies typically do not include consideration of viable agroecological alternatives that provide multiple ecosystem services and have been shown to be highly productive and profitable. Similarly, conventional breeding methods often can accomplish what more controversial genetic engineering has been predicted to accomplish, but has often failed to do. So in virtually all cases, alternatives exist to GE approaches, and in most cases those alternatives have advantages over GE “  [as in the US’s National Environmental Policy Act and other similar environmental assessment statutes which require the simultaneous evaluation of alternatives]

Good morning to all!
I thank Maria Mercedes, the Online Forum and the Secretariat for the output of the first round of discussions. María Mercedes concludes that the vast majority of participants are not really in favor of developing specific guidance for Synthetic Biology, not at least for now.
Nevertheless, as she also pointed out, it is clear that there is a need for further development on the concept of “comparators” under the guidance in relation to identifying appropriate comparators. Equally important is the fact that synthetic biology involves increased complexity and uncertainty, facts that might be taken up through adapting or adding to the risk assessment methodology.
Many examples have been already documented under the CBD process, the ones I am most worried about are those which are developed almost as if it was a type of “sea monkey”….. take it out of the box, add water and play system …..what I mean is that the technology is at the reach of almost anybody with really no specific restrictions to what, and where something can be developed and used (even though it was also stated that most developments are destined to contained facilities and are not meant to be released into the environment).
I personally believe we must not wait for a COP-MOP decision as the sort proposed in the last section of the summary presented but find a way forward to start working on specific examples for which we realize the existing Guidance falls short, as well as developing some helpful ideas on comparators, as well as additional Q´s that must be raised during the risk assessment process. I do support the development of a mechanism that can monitor new biotechnological developments, this will additionally be helpful. I therefor support the AHTEG on Risk Assessment and Risk Management giving it a go so as to provide further tools to the COP-MOP and COP.
Un abrazo,
Fran

Good evening,
Many thanks to Maria Mercedes for chairing, Secretariat and Participants for discussion.
I think valuable source of information that we could use also during our discussion which contains inter alia examples on Syn Bio is submission of information provided by the Parties, other Governments, relevant organizations and stakeholders on BCH http://bch.cbd.int/synbio/submissions. For me viruses, microbes or algae for uncontained use (bioremediation, fuel production, etc) produced through Syn bio at this point are the reasons why it is necessary to develop new tools and, where changes are so great or can not be evaluated using the existing guidance, to develop the new guidance.
I agree with Jack`s reasoning presented in Doc. “Possible considerations during the environmental risk assessment of LMOs developed or created through approaches commonly referred to as “synthetic biology”. Just addition to “LMOs containing an increased number of modified traits". For me this issue is as important as the Comparative approach and this point is one of the most important reasons to start develop tools and Guidance on Syn bio. For complex systems similar doesn`t mean the same, it is generally known that novel combination of even known parameters can give rise to novel traits and unpredictable effects. It could be a challenge to estimate effects e.g. long-term effects of new processes created in new organism, especially from Syn bio organisms with numerous changes or organisms produced through xenobiology.
I agree with Franciska, it is not premature to start thinking on the comparator approach for Syn bio. In addition reflecting on how to be when there is no comparators it is also important to notice that monitoring tools need to be paid more attention. I believe that monitoring chapter is one of the important chapters of the Guidance and  need to be further developed in application to Syn bio. In addition, for some of such organisms it would be very helpful to coordinate efforts with  experts on detection and identification as this area is also very important as part of monitoring process and could be a challenge.

Dear Colleagues.
I find the discussion is slowly diverting to a purely abstract ground. As I and others stressed before, it would be advisable to have clear examples of LMOs derived from synbio that lack a proper comparator or that otherwise pose a real challenge to the regulator.
Complexity in itself is no reasonable reason for new regulations: the farnesene (artemisin)-producing yeast has dozens of small genetic changes, but is entirely predictable and was no challenge for Brazilian regulators.
I am confident that these examples will materialize, especially from those proposing a deeper discussion of synbio regulation now.
Kindly
Paulo Andrade

Dear participants,

First thank you Maria Mercedes for moderating this round of an important discussion.

Acording to our task I would like to propose revisions to the text of the document “Doc 1 Secretariat Synbio RARM”. The Secretariat explained that our task is “to submit to the COP-MOP scientific and technical advice that will assist the Parties in making a decision whether or not guidance on risk assessment of LMOs developed through synthetic biology is needed”.

Having this goal on mind I think is very important to capture and express in this doc the different views collected in the SynBio and RA AHTEG and in the different rounds of on line foruns about some relevant topics for the Parties to have a transparent and informed decision.

I also agree with Paulo Paes (#7984) about the importance of those that advocate for a SynBio  guidance to present examples that pose a real challenge to the regulator so we can work in a concrete basis.

Thank you.

Best regards,
Luciana P. Ambrozevicius / Ministry of Agriculture - Brasil

First, I’d like to thank Maria Mercedes for chairing this important discussion.

In the text for discussion, states that The AHTEG on Synthetic Biology agreed on a definition. That’s not precise, actually, the AHTEG on Synthetic Biology aimed towards an “operational” definition (see item 3: “Towards an operational definition of synthetic biology… on UNEP/CBD/SYNBIO/AHTEG/2015/1/3 item 3) to make the discussions  possible. At this stage, there is no clear or internationally accepted definition of what comprises Synthetic Biology. Several considerations to reach a definition in a responsible way must be included (such as social, legal, etc. issues), nothing that could be achieved during the AHTEG meeting. 

It’s also not prudent to include techniques to Synthetic Biology, as often there is not a clear boundary. As an example, the text for discussion erroneously mentions genome editing as if it were accepted as Synthetic Biology. Actually, some genome editing tools are under consideration as New Breeding Techniques, i.e. whether its conventional breeding or a GMO.  Some gene edited products do not differ to those mutations that occur in nature, do not contain foreign DNA, and are similar to conventional breeding.  In fact, for instance the competent authorities of several European Member States (including UK (ACRE), Germany (The Federal Office of Consumer Protection and Food Safety [BVL]), Belgium, Holland, Sweden have independently stated that they did not consider some  products of Oligonucleotide-Mediated Genome Editing  or Oligonucleotide directed mutagenesis such as the Cibus Canola as an LMO. According to these European member states analysis this product fits to New Breeding Technique or non-GMO definition. In addition, the AHTEG on Synthetic Biology discussed and also concluded that adding tools and techniques to the definition of Synthetic Biology was not possible.

As stated in the text for discussion, “many experts in the various fora that contributed to this process were also of the view that the current methodologies for environmental risk assessment of LMOs are fully adequate to assess the risks of organisms developed through synthetic biology and, therefore, no further guidance is needed.” As the technology develops, the Risk Assessment and Management methodology could be modified to accommodate new specific considerations related to synthetic biology should the need arise.  Therefore, I agree with those colleagues that include Paulo Andrade, Luciana Ambrozevicius that first we need to identify specific examples that need a different approach or present a real challenge for the current risk assessment and management.
thank you

I support the revised text by Luciana P. Ambrozevicius [#7985] almost entirely.

My specific comments are as follows.

1. I thank Luciana for reminding us of the discussion and conclusion of SynBio AHTEG. It is highly problematic to mix up synthetic biology with specific techniques which may be used as a tool in synthetic biology. For example, genome editing techniques may be used in synthetic biology, but the same techniques are also used for the introduction of simple base substitution or short in/del, which, per se, are not synthetic biology by any means. References to specific techniques should be avoided as far as possible.

2. In the absence of any realworld example of SynBio organism which challenges current risk assessment methodologies, I think the most important thing is to keep "monitoring and assessing the state of knowledge within the field of synthetic biology on a regular basis". Although establishing and maintaining such mechanism is not a task of this forum, it is worth reminding COP-MOP of this importance to help its deliberation.

3. I support the deletion of the last paragraph (Detection and characterization). Annex III already requires that risk assessment takes into account, depending on the case, detection and identification methods and their specificity, sensitivity and reliability. Many regulatory frameworks, including ours in Japan, require the developer or importer to have means to detect and identify LMO for intentional introduction into the environment. This also applies to SynBio organism, of course, as far as the organism is regarded as a LMO within the regulatory framework. Technical aspects regarding detection and identification of LMO, including capacity building activities, are being dealt with in another forum. In addition, for the reason mentioned above, references to specific techniques (genome editing) should be avoided.

4. As for the DIY biology, I just wonder if biosecurity and dual-use issues including "the exchange, distribution and commercialization of the components of modern biotechnology" are within the scope of CPB.

Nobuyuki Fujita
National Institute of Technology and Evaluation, Japan

Although genome editing technology is not regulated in some countries, it is artificially manipulated and different from the conventional way. This should be assumed as a kind of new breeding technology (NBT), while the definition of NBT also includes synbio. The genome editing technology shall be regulated any way. The escaping process of a gene drive element into wild population is different from the way of the transgenes in GMOs, which may not follow common genetic segregation (e.g. Mendelian law) in the progenies. This may bring challenge to the risk assessment. This is of course a good example that requested additional attention.
    For the recreated/created pathogens (microbes) produced via synbio, it may be difficult to find a current comparator to conduct assessment. For example, the 1918 H1N1 influenza virus.
    In the regulation of GMOs, the developers has provided methodologies for detection to meet the request of commercialization, but many researchers still work on this issue to correctly detect and monitor the presence of GM materials. This also applies to synbio. Thus detection and characterization are still challenges for the assessment of organisms derived from synbio.
    In addition, I believe that CBD focuses on all issues that are related to the conservation and sustainable utilization of biodiversity and fair benefit sharing arising from the utilization of genetic resources. Once the DIY synbio has an impact on those issues, the CBD shall take its role.

Dr. Wei, good morning.

I would like to point out that although synbio may be classified as a new breeding technology, not all NBTs are synbio, including genome editing. Indeed, genome editing is just a technique and can be used to generate point mutations, indels, etc., as well as to produce larger editions, and has no direct connection to any reasonable definition of synbio.

Moreover, although gene drives are now obtained through genome editing, they can be obtained by other techniques. Gene drives are perhaps more challenging for the regulator, but it strongly depends on the specific gene drive organism. For instance, gene drive mosquitos for population suppression turned out to be quite simple to assess, as the participants of a recent workshop on that subject could unanimously conclude. As gene drives are no synbios, I think the discussion is interesting but irrelevant in the moment.

I don´t see either how a synbio pathogen could be of interest to the market, except an attenuated pathogen. Anyway, it will be just the original pathogen, with a couple of new sequences or the deletion of others, and not such an extensively edited genome that would produce an otherwise totally new organism. The comparator is, to my opinion, not a challenge at all.

Detection of synbio organisms, especially those having many genetic changes, will be quite easy. Here, also, I can´t imagine which could be the real challenge. And although detection os important for LMO management, it is usually not a key question in risk assessment per se.

I therefore keep insisting that we should have clear examples of synbio organisms to discuss R.A. in real bases.

Kindly
Paulo Andrade

Good morning to all!
I thank the online forum Colleagues and the Secretariat for the discussion and to Maria Mercedes for moderating it.
I wish to share with you some general consideration.
I think that the most important hot spots of the discussion have been highlighted by Nobuyuki Fujita (#7987) and that many colleagues, Paulo Andrade, Luciana Ambrozevicius, Lúcia, have already pointed out a way forward, specially in relation to the need to have real world- actual examples to work. In my opinion, having these examples would help in defining the boundaries and field of application of Synthetic biology.
I do agree with suggestions made by Wei (#7969) and Lúcia (#7986) about the incipit of the document. In particular, I suggest to delete the third paragraph avoiding any reference to gene editing, gene drive or any other specific techniques and/or approaches; this taking into account the ongoing discussion at international level and the lack of consensus on the issue.

I have made my specific comments, in track changes, on the revised text by Luciana P. Ambrozevicius #7985, that I support.
Please see the attached .doc.
Valeria

Dear All.

I fully support the revised document sent for assessment by Luciana, with contributions now from other colleagues. It encompasses the consensual opinion, but also reflects the minority opinion. It is clear, objective and respectful and can well be used to support further discussions at the COP level.

Kindly
Paulo

I support the revised text by Luciana P. Ambrozevicius [#7985]. It is very important to have clear concepts and objective purposes and avoid subjects with different scientific views are mistakenly mixed.

Dear Luciana and colleagues,

Thanks for Luciana's comments [#7985], but I can not agree to.

First of all, it is not a good time to discuss the policy whether we need to develop the guidance as suggested by the moderator. It is not wise to count the percentage either as we are not going to elect a president. In stead, we are going to do the risk assessment, for which the precautionary principle is a very important factor that we shall take into consideration.

Secondly, people may also remember the history of the  Cartagena Protocol on Biosafety. Parties started to develop and negotiate on it in the end of last century, earlier before the commercialization of GM crops. Now we are still discussing on this protocol and a lots issues still need to be solved. Risk assessment is something we need to put in place before a risk, other than wait until for the risk. I do not think it is premature to develop guidance docs for organisms produced by synbio.

In addition, I do not see the reason why someones always assume premature either for the roadmap documents for LMOs or for the organisms derived from synbio. Anyway, I would prefer not to talk again on whether or not we need to develop guidance.

Thank you and Best regards!

Wei

Dear Dr. Wei Wei and participants,

I do think is premature to develop a SynBio guidance:

- the precautionary approach for SynBio organisms is taking into consideration as it´s mentioned at each COP decision about SynBio. We do not need a guidance for that

- the definition of SynBio was not agreed by countries at SBSTTA 20, we will write a guidance about something that is not defined

- the current and near future SynBio organisms are LMOs and the current methodology for risk assessment of LMOs is applicable (and we already have the RoadMap for LMO RA)

- the Parties never gave a green light for this SynBio Guidance: the SBSTTA 20 only described the necessity of a coordinated approach between the AHTEGs

- till now the participants in favor of a guidance did not present one example of a SynBio organism for which the RA is not applicable

- till now the participants in favor of a guidance did not mentioned any specific aspect of RA that is a specific challenge for SynBio, only present general issues (comparator, complexity, uncertainty, detection) 

- there are two AHTEGs and the SynBio AHTEG, where are the SynBio experts, is responsible for all the subjects related with SynBio but not for the guidance. When a guidance is needed for specific aspects of SynBio it makes sense to be written by the experts

I also I think is necessary to count the contributions in the on line forum because is the voice we have. There are not many countries that are part of the AHTEG and our participation in the on line forum means that we want to be represented in this entire process and we want a transparent and real report at the end. It is very curious when we have a process where there are 26 experts saying they don´t want a guidance at this moment and other 4 experts saying they want and even though with such a discrepancy the idea of a guidance is going on.

I would like to register again that even though I had suggested changes in the Secretariat outline draft I do not agree with a guidance at this moment, the position that the brazilian delegation presented very clear at SBSTTA 20.   

Best regards,
Luciana P. Ambrozevicius

Dear Luciana,

I do believe that the guidance is very much necessary regarding the current advance of synbios. Anyway, we leave it to the decision of cop.

I am sorry that did not have a post during the first round of online discussion due to workload. I think many others may have the similar situation with me. If necessary, I would like to call our Chinese colleagues to come here to vote. Or we can call all the parties to vote. But voting is not the right way.

Best wishes

Wei

Dear All.
I thank the online forum Colleagues and the Secretariat for the discussion and to Maria Mercedes for moderating it.
I support the revised text posted by Luciana P. Ambrozevicius where reflect all opinions, consensual and minority. It is very important to have clear concepts and objective purposes that can be used to support the discussion in future meeting at COP level.
Best regards,
Maria José Vasconcelos / Embrapa, Brazil

Dear All.

After revising all comments posted in this forum, I think an adequate summary of the most important questions is:

a) Comparators. Some colleagues argued that synbio organisms may miss a proper comparator. However, as synbio definition is far from consensual, the problem of finding a convenient comparator may arise in other products derived from other biotechnologies. It would be advisable, therefore, do reassess the question of an adequate choice of comparators in a broader scope and when real-life products with challenging comparators do appear, preferentially still in the steps of confined releases or lab experiments. In the absence of clear examples of products that lack a proper comparator, and because of the reasoning above, many of the participants believe it is premature to dedicate any more attention to this question.

b) Complexity. Some colleagues also argued that synbio organisms are usually much more complex (in terms of the extent of genetic modification) that regular transgenic organisms. Again, as a definition of what synthetic biology is not consensual, the borders of different technologies are blurred. Moreover, complexity in itself is no challenge in the case of many organisms that have been modified for decades, like microbes. Even invertebrates, like Drosophila or Caenorhabditis, also extensively modified, were really no challenge to the regulator or the risk assessor. The challenge may derive, however, fromm a single change, and this is why risk assessment is always case-by-case.  Again, challenges are an integral part of the daily work of an LMO risk assessor, irrespective of what specific technology was used to generate the product. This is why many of the participants don’t see the point in having specific guidance for synbio based on an “a priori” complexity.

Irrespective of an absolute counting of voices favorable or against the need of specific guidance, it clear in my mind that arguments in favor of such guidance aren’t based on real life examples and lack a broader set of elements based on previous experience with LMO risk assessment. The two questions, namely comparator and challenges associated with specific (numerous) new traits will persist and will always be present in risk assessment.

Kindly
Paulo Andrade

Good day and thank you for the intervention by Paulo Andrade from Brazil.  As a Canadian biotechnology regulator, I must say I fully agree with his thoughts on comparators and complexity. These are not new challenges to risk assessors and are not necessarily linked to 'synthetic biology' derived organisms - acknowledging the difficulty we all have even to identify what examples we have of such organisms! 

Jim Louter, Manager, Biotechnology Section
Environment and Climate Change Canada
Government of Canada
http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=E621534F-1

Recalling the opening intervention and welcome from our moderator, Maria Mercedes, and her instruction to:

      "Your task during this discussion is to either support, or not, each of the considerations in the document based on scientific arguments. Identifying concrete examples of current and foreseeable LMOs that present novel and specific challenges to the general principles and methodology of risk assessment will be most helpful. Proposals for revisions to the text are also welcome."

and therefore, I am attaching my comments to the document she referred to.

Jim Louter, Manager, Biotechnology Section
Environment and Climate Change Canada
Government of Canada

Dear colleagues,

to start with: Thanks a lot to Maria for moderating this online forum and for providing us with her summary of the previous online forum on synthetic biology.
Regarding the current discussion, I can for the most part support the revised text by Luciana Ambrozevicius [#7985]. The SBSTTA could not reach consensus about the operational definition by the AHTEG. It will thus be difficult to discuss a guidance document, when no commonly accepted definition exists.
A point of high importance that has been made by Luciana Ambrozevicius and several other ([#7987], [#7990], [#7986], [#7991]) is the inclusion or exclusion of techniques into a definition of synthetic biology. The AHTEG has not listed techniques of synthetic biology, because the degree of overlap with techniques of modern biotechnology is too high. Techniques such as gene drive or genome editing must not be used synonymously for synthetic biology! These techniques can be used in synthetic biology, but also in conventional biotechnology and therefore must not be taken as a pretext to develop a new guidance on synthetic biology as it has been claimed by Jack Heinemann [#7971].
However, I think it is generally accepted that techniques like gene drive may need a special risk assessment on a case-by-case basis. In this context, I would like to mention that the German Central Committee on Biological Safety (ZKBS) recently has released a position statement that will oblige a case-by-case risk assessment for any gene drive system (http://www.bvl.bund.de/SharedDocs/Downloads/06_Gentechnik/ZKBS/02_Allgemeine_Stellungnahmen_englisch/01_general_subjects/Recombinant_gene_drive_systems.pdf?__blob=publicationFile&v=3).
I can support Luciana Ambrozevicius addition to the paragraph “Potential to alter entire wild populations”. I would, however, prefer if gene drive systems weren’t dealt with at all in the context of synthetic biology, because the technique is not synonymous with synthetic biology.
I also support her point made on DIY-biology. DIY-biology is not a specific issue for synthetic biology and has to be dealt with in other fora.

Best regards,
Swantje Strassheim

Dear Swantje, dear colleagues.

Gene drive-containing organisms will be regarded as GMOs (or LMOs) in most regulatory frameworks. Their risk assessment will consequently be case-by-case, step-by-step as usual. In a recent hands-on exercise promoted by the Foundation of the NIH and conducted by ILSI in Reston (USA) it became clear the usual approach for Problem formulation does apply to gene drive-containing mosquitoes for unconstrained used: the identified relevant risks, indeed, were just a few, at least for Anopheles gambiae. A report will be published soon.

The recurrent proposal of gene drives as potentially much more dangerous than regular GMOs just because of gene flow is, in my opinion, wrong and may be exploited as an argument to unscientifically restrict the use of the technology in future products. Even worst is the mistaken connection of gene drive and synthetic biology, as pointed out by Swantje and clearly explained in the annexed report in her e-mail. The connection of genome editing and gene drives to synthetic biology is detrimental to the development of new product with a high potential use to mitigate diseases and agricultural pest, to cure and prevent diseases and to improve biotechnology as a whole, and should be deleted from every meaningful discussion in the future.

Kindly
Paulo

Dear members of the forum,

Thanks to Maria for accepting to moderate this discussion once again and thanks to the Secretariat for organizing this and providing the draft text.

I have provided my suggestions and arguments in the document in attached. I have uploaded Valeria's version but I have also added Jack's comments which were not included before. In the meantime, I have missed Jim's comments on my revision.

In short, I have agreed to some suggestions made by others but also disagree with some deletion or addition of new text. My arguments are provided.

I dont see a strong reason to keep the section on DIY. On the other hand, I would strongly like to keep the section on detection, which is not about detection of synbio itself but rather molecular characterization. Perhaps a new title could clarify that.

I would like to agree with Jack's opinion on new qualitative changes of synbio organisms because the complexity should not be interpreted as the effects of the sum of many new parts but rather new interactions and synergistic effects of these many novel parts.

At last, it is quite intriguing to me why some participants remain skeptical about the synbio pipeline and products when all the scientific community already discuss the applicability and commercial stage of synbio organisms and products (e.g. http://www.nature.com/articles/nplants201610, http://www.nature.com/nrm/journal/v15/n4/full/nrm3767.html, http://www.nature.com/nature/journal/v531/n7594/full/531401a.html). Parentheses again for the fact that these literature references also cite farnesene from Amyris as synbio product/organism. Moreover, RA is a pre-market step and we should be able to treat such new products before they enter the market, not after. Therefore, I dont see relevance in continuous calling for "concrete" examples, even when many "concrete" examples were already mentioned by many participants before.

Best regards,

Sarah Agapito

Dear Colleagues,

I provided two examples of the applications of synbios for your reference. Together with others, those are desired for specific framework of risk assessment.

1) a synthesized bacteriumis can propagate stably with expanded genetic alphabet.

Malyshev, D. A., K. Dhami, T. Lavergne, T. Chen, N. Dai, J. M. Foster, I. R. Correa, Jr. and F. E. Romesberg (2014). A semi-synthetic organism with an expanded genetic alphabet. Nature 509(7500): 385-388.

2) Synechococcus elongatus expressing a synthetic operon containing invasin from Yersinia pestis and listeriolysin O from Listeria monocytogenes can invade and replicate inside mammalian macrophages and resulting in artificial animal chloroplasts.

Agapakis CM, Niederholtmeyer H, Noche RR, Lieberman TD, Megason SG, Way JC, et al. (2011) Towards a Synthetic Chloroplast. PLoS ONE 6(4): e18877. doi:10.1371/journal.pone.0018877

Thank you!

Wei

Dear members of this forum

In response to some of Sarah Agapito´s comments and information and to Dr. Wei comment, I would like to reinforce the lack of suitable real-life examples of synbio products:
a) The three papers linked in Sarah´s post do not bring to light any real undisputable synbio products near the market. Rather they discuss the future of synbio in broad lines and specially its contribution to science and innovation. The most probable scenario is the delivery of a new product derived from synbio studies, but produced either by regular biotechnological approaches or by new tools as genome editing.
b) Again, although the farnesene-producing yeast was presented by Amyris and other partners as a synbio product, it was treated as a regular GMO by CTNBio. This happened because the borders between synbio and regular genetic engineering are blurred. Other similar products on the pipeline and still others which are plain genetic engineering are been advertised as synbio just because they have some synthetic polypeptide designed by bioinformatics, but cloned and expressed in a standard transgenic system (for some examples, check the penultimate paragraph of Church et al. paper linked by Sarah - http://www.nature.com/nrm/journal/v15/n4/full/nrm3767.html).
c) If we take the Amyris yeast as synbio, it will definitely prove that risk assessment challenges are minor for this case: the many genetic changes are very predictable and the comparator is evident. Maybe the ease in doing the R.A. for this LMO was due to the broad and deep knowledge accumulated during centuries on Saccharomyces, and such extensive genetic changes in a less known organism could pose a challenge, but as R.A. is always case-by-case generalizations are usually on limited use.
d) The examples brought by Dr. Wei are indeed interesting from the point of view of Science, but they are still very far away from any practical application. Synthetic biology has a large amount of interesting organisms, but those with a chance to reach the market in the next few years will possibly be those with very predictable outcomes based on very well-known organisms of agricultural, medical, environmental or industrial use. All the extraordinary creations will most possibly be used to generate new knowledge, not as daily life products.

I therefore keep with my opinion, which is shared by most colleagues in this and in the previous forum: there are no clear examples of synbio products in the pipeline or in the market. Without such examples the production of specific guidelines is very speculative and of limited use.

Kindly
Paulo Andrade

Dear Maria, Dear all

Apologies for not being able to participate in the discussion earlier due to work load.

I would like to start my intervention by writing down some comments to the views expressed in the current discussion:
a. The need for a guidance document to assist parties to conduct risk assessment for organisms, components or products resulting from synthetic biology techniques is not questionable. Recalling CBD. COP decision XII/24. 3
“Urges Parties and invites other Governments to take a precautionary approach, in accordance with paragraph 4 of decision XI/11, and:
- To establish, or have in place, effective risk assessment and management procedures and/or regulatory systems to regulate environmental release of any organisms, components or products resulting from synthetic biology techniques, consistent with Article 3 of the Convention; “.
The parties have the mandate to establish effective risk assessment for such organisms and to do so parties especially the developing ones need appropriate guidance.
b. In expressing the views that are reflected in the discussions we should not use quantifying words such as majority, minority... The construct and the composition of the online forum participants although they serve the purpose for which this forum was established (to assist the AHTEG to perform its tasks by providing valuable inputs and comments to the process through brainstorming) do not represent a balanced sample. Otherwise 20 persons working for the same company/ government/ institution may say the same position and then claim they are majority and that most of the forum participants think this way.

Getting back the topic of the discussion, which is the development of a guidance document on synthetic biology.  I believe no body denies the complexity of the issue due to the fact that Synthetic Biology is a rapidly evolving technology. Trying to have a restrictive definition is not advisable. Then comes the question how can we develop a guidance for something that we are not able to agree on a definition for the time being.

I think one way forward is to have a general broad definition then we can go the case study level or I would better call it examples level. In this level, we can highlight the novel Synthetic Biology developments according to the used techniques. For example; 1) Genetic part libraries and methods; 2) Minimal cells and designer chassis; 3) Protocells and artificial cells; 4) Xenobiology: 5) DNA synthesis and genome editing; and 6) Citizen science (Do-It-Yourself biology (DIYbio)).

And for each of those cases/ examples we need to try to answer the following questions;
On Risk Assessment:
- What are the potential adverse effect for human and animal health and the likely environment of the developments in Synthetic Biology resulting or not in a genetically modified organism?
- Are existing risk assessment and risk management methodologies appropriate for assessing the potential risks associated with different kinds of activities, tools, products and applications arising from Synthetic Biology research?
- If existing methodologies are not appropriate, how should existing methodologies be adapted and/or completed?

On Risk Management:
- Can safety be inherently built into products of Synthetic Biology? How, when, and to what extent?

It is important to highlight that the framework for risk assessment of new Synthetic Biology products may be addressed using current methodology used for GMO risk assessment. Risk assessment must consider hazard identification and characterisation, exposure target, degree of exposure, trends in exposure and number of exposed. However, there are specific cases in which new approaches may be necessary. These include, among other, risks pertaining to 1) routes of exposure and adverse effects arising from the integration of protocells into living organisms and future developments of autonomous protocells, 2) new xenobiological variants and their risk on human health and the environment that should be engineered for improved biocontainment, 3) DNA synthesis and direct genome editing of zygotes which enables modifications in higher animals within a single generation, and 4) new multiplexed genetic modifications which increase the number of genetic modifications introduced in parallel by large-scale DNA synthesis and/or highly-parallel genome editing and will increase the genetic distance between the resulting organism and any natural or previously modified organism.

And in this regards, one should understand that the rapidly evolving nature of this technology implicates that risk assessment of and methodology for Synthetic Biology must be revisited at regular intervals.

Regards,
O.A.El-Kawy

Dear Dr. El-Kawy.

I am sure most of us agree that new products classified as LMOs must have their risks assessed and that, as you stressed, the usual approach to risk assessment, embedded in the AHTEG guidance, is now adequate to assess risks of products in the market or in the pipeline of approval.

I also agree that protocells and other particular creations of synthetic biology may be a challenge for the risk assessor, but as the Cartagena Protocol does not rule how countries should regulate LMOs in their own territory, we should wait until such creations are transformed in products on the pipeline of commercial approval (e.g., from field releases to commercial release), with a sizable probability of transboundary movements, to produce meaningful guidance to countries with insufficient GMO R.A. practice.

Taken your example, I would say that autonomous protocells may be used in the future, but for the moment this is far from being a product, not even in the beginning of the R.A. pipeline. Moreover, R.A. is always case by case and if we don´t have innovative cases coming from synbio and in the pipeline, the discussion will be very theoretical and of limited used exactly for the countries in most need of a guidance. I would like to remember that the pipeline is long and the transit is slow, and it will be even slower if the product carries challenges in its risk assessment. Before they start to transit between countries which are signatories of the Cartagena Protocol I am sure the challenges will be adequately discussed and then, but only then, it will be the right opportunity to discuss if the present R.A. rules are adequate.

On the other hand, genome editing and gene drive are not an integral part of synthetic biology: the first technique can also be used to produce very simple indels and to create new products much more precisely than ever before and not necessarily with lots of genetic changes. Moreover, as I commented before, complexity is not inherent of synbio nor exclusive of it. Many genetic changes stacked in a single event are expected, derived from synbio or by other processes, but their R.A. will possibly be no more challenging than what we already have in stacked plants. Indeed, the number of individual genetic changes is rather irrelevant for the risk assessor: what is important is the phenotype and if the generated organism behaves very different from its parental strain it would be a challenge for the assessor, irrespective of how many changes have been introduced.

The second technique (gene drive) just changes the Mendelian inheritance and hence, gene flow. As gene flow is a paramount question in regular GMO risk assessment, and very much discussed in every risk assessment, I definitely don´t see why products using this technology deserve a special guidance.

My most important remark, however, is: there is no reason to connect genome editing and gene drives to synbio, as both techniques can be, and indeed are, used in connection to products far away from any reasonable definition of synbio.

In the hope to have contributed to a fruitful debate, I congratulate you and all our colleagues in tis forum for the exciting discussions.

Kindly
Paulo Andrade

Dear Maria, Dear Colleagues

I would just like to clarify that there is no disagreement that the synbio examples given by me and other colleagues are LMOs. In fact, synbio examples discussed here are a type of LMO and because of their peculiar characteristics they require special consideration during risk assessment.

Thank you,

Sarah Agapito

Dear all,
Thanks to the Secretariat for the document that is now under discussion and Maria Mercedes for her moderating. It is not the most easy discussion to moderate.

I would like to support the views, suggestions and interventions of a number of my colleagues such as Luciana, Nobuyuku, Paulo, Lucia, Valeria and Jim (#7985, #7987, #7999, #7986, #7991 and #8001).
I have attached the background document under discussion, including my comments in tracked changes.

Kind regards and have a nice weekend!
Boet

Dear all—

I would like to add my thanks to Maria Mercedes for moderating this discussion and to all the participants for their informative contributions regarding the Secretariat’s draft.  My apologies for not being able to join the discussion sooner.

I support the document edits and comments proposed by Luciana P. Ambrozevicius, #7985, Valeria Giovannelli, #7991, Jim Louter, #8001, Boet Glandorf, #8010, and additional comments by others such as Paulo Andrade and Noboyuki Fujita.  The Secretariat’s discussion document includes a series of considerations offered as an “indication that current assessment methodologies may need to be adapted to assess the risk and safety of such LMOs”.  Rather than solely indicating our support, or not, for each of the considerations as Maria requested, I think it will be helpful to the delegates to the COP-MOP to also clarify the implications for a way forward, as Valeria did in her edit. 

I fully support her suggestion to include the conclusions and recommendations of the Synthetic Biology AHTEG as still being the best way forward after reading the contributions to the forum to date, that is continue to monitor the technology and coordinate with other organizations doing the same.

If others conclude that an update to the existing Guidance on Risk Assessment of Living Modified Organisms is warranted at this time, I offer as an alternative approach the recent (2012) update of the former “NIH Guidelines for Research Involving Recombinant DNA” to the current “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules”, that is, an update to include the newer techniques of synthetic biology.  These guidelines are to be followed by all federally funded researchers working with LMOs in US laboratories.

Several helpful (but modest) changes were made, including a concrete suggestion about how to deal with comparators for organisms with components from several sources.  The major change was to make clear that risk assessment and risk management guidance developed for earlier generations of biotechnology applied equally to organisms modified using the techniques of synthetic biology. No separate section or chapter was needed. The intent, similar to the suggestion from the synthetic biology AHTEG, is for the NIH to continue periodic reviews to accommodate future developments, continuing to make changes if needed.  (And as an aside, note that the various experiments presented by Wei Wei in #7989 and #8005 were all reviewed under this guidance.)

I think it is also important to point out where other international organizations are taking the lead for specific LMOs.  This information will help the delegates better understand whether and what kind of additional efforts are needed within the Cartagena Protocol. 

As requested by our moderator, I have added additional suggestions directly to the text, starting with the version that includes Luciana’s and Valeria’s comments and edits.

Regards to all,
Bob Friedman

I thank the secretariat for their work and Maria for moderating.

My view is that that synthetic biology, while sharing some characteristics with other LMOs and methods of producing LMOs that are already covered in the Guidance, is also sufficiently different from those other methods, that it deserves a specific section to ensure that all pertinent aspects of this new technology are covered in a risk assessment. 

In my view, the examples given in “Doc 1 Secretariat Synbio RARM” are very relevant, particularly the difficulties in finding a proper comparator for synthetically-generated organisms, and the potential for synthetic biology to generate gene drives.  It should be noted that gene drives are already being promoted as a means of wiping out entire species by design – eg some species of mosquitoes that carry disease. 

Furthermore, as the Secretariat says (“Doc 1 Secretariat Synbio RARM”), the accessibility of synthetic biology to the general public through “do it yourself” synthetic biology projects leads to particular risks that need addressing. As a real world and current example that can pose a problem to a regulator, an article in New Scientist (13 February 2016, page 20), titled “Make your own life form”, reports that kits that allow the general public to do this are already on sale.  Specifically, it reports that “at an event for synthetic biology start-up firms in San Francisco” in February of this year, “Amino Labs showed off the Amino One”, a briefcase-sized “table-top lab for the consumer market”, where “beginners will be able to modify bacterial cells to create medicinal chemicals, scents and even foodstuffs such as yogurt, beer and bread.”  The company provides recipes to users, one of which allows users to “tweak E. coli’s metabolic pathways to produce violacein, an anti-parasitic compound used in cancer research”. In addition, “Amino Labs wants people to improvise, hacking together different scents and materials”.  The article makes it clear that these kits will by now have been shipped to people who backed its crowdfunding campaign and that “the price is expected to fall to a few hundred dollars once the company begins mass-producing the devices in 2017.” Given that other companies are likely to follow suit and that the capacity of the biotechnology achievable by such kits is only likely to increase, countries may wish to regulate the importation and development of such kits, given that they will be used in uncontained environments (eg the home) and are likely to result in LMOs being flushed down the sink to enter the environment, including the water supply.

While various contributors have argued that no products of synthetic biology have yet been released into the environment, they cannot argue that none are being developed.  And while there have hopefully been no accidental releases of these organisms from a laboratory into the environment, it would be prudent to give governments the tools to undertake a risk assessment of these organisms to determine the level of laboratory containment required for each, on a case-by-case basis. 

I also agree with Sarah Agapato-Tenfen [#8004] that a risk assessment of such organisms is a pre-market step and tools should be available to assess them before they get to market.

I therefore argue that there is an urgent need for specific guidance for synthetic biology to be developed.

I therefore agree with the views expressed by Jack Heinemann [#7971], Francisca Acevedo [#7980], Galina Mozgova [#7982], Ossama AbdelKawy [#8007] and Wei Wei [#7989, 7994, 7996]  amongst others, that additional guidance should be developed for risk-assessing synthetic biology. 

I therefore support the document titled “Doc 1 Secretariat Synbio RARM” as proposed by the Secretariat.

My only suggested changes to the document are here:

At the beginning of the sixth paragraph, delete: “The views expressed in this document do not reflect consensus or the majority of views. Instead”, on the basis that if several people (including myself), had not been less busy during the previous discussion on synbio, the “majority view” may have been quite different, so that the paragraph now reads “This document attempts to compile views on which considerations could be particularly relevant during the risk assessment of organisms developed through synthetic biology.”

At the beginning of the twelfth paragraph, the words “While synthetic biology aim at increasing the precision..”  would be better expressed at “While synthetic biology aims to increase the precision…”

In the third-to-last paragraph, the phrase “ formally established laboratory facilities” would be better written as “formally-established laboratory facilities”.

Some contributors (eg #7987) have suggested deleting the last paragraph of “Doc 1 Secretariat Synbio RARM”.  I do not support this suggestion.

I agree with Ossama AbdelKawy [#8001], that synthetic biology is a rapidly developing area, and so I agree with the view expressed in the last paragraph of the moderator’s summary of the previous AHTEG discussion on synbio: “A possible way forward is for the COP-MOP to establish a mechanism, such as an online forum, to monitor biotechnological development and enable the identification of such examples”. The guidance should be regularly updated to include new developments.

Dear all,

I thank the Secretariat for their confidence in inviting me again to moderate this most lively and interesting forum that reflects different opinions regarding risk assessment  and risk management for synthetic biology (SB). I also sincerely thank the many participants that have shared their opinions and experience with the group, with special thanks to Paulo and Wei Wei for their most valuable interventions, with opposing views.

Before the forum closes tonight, I am sharing with you a moderator´s summary that attempts to reflect the wealth of information and views shared by participants. Although as moderator, I kindly requested that you made comments to the text provided by the Secretariat (Doc1 – Background document  Synthetic Biology  RARM) and either supported the contents of the document, or not,  I agree with Phil that procedure and policy considerations  in these issues are very important. 

In the spirit of transparency and to give parties are fair view of where the weight of expert opinion lies in this rather contentious issue,  I consider that quantifying and qualifying the opinions of participants  will provide and more balanced view  for parties at COP-MOP to make a decision. It is my hope and my respectful request, that the Secretariat takes these views into consideration, when drafting their report for COP-MOP discussions.

Please feel free to correct any mistakes you find in the following summary:

1. There were 40 interventions from the following countries and organizations: Brazil, USA,  Canada, Mexico, Netherlands, Belarus, Italy, China, Japan, Mauritania and New Zealand.  Again, the voice of small developing countries and least developed countries (with the exception of Mauritania)  was absent.  The discussion was dominated mainly by those countries that have historical and  practical expertise in risk assessment of LMOs.

2. As requested, 7 participants provided  alternative  text  to Doc1. For  those 7 submitted documents with alternative text to Doc1,  3 advocated for the development of further guidance for synthetic biology (SB)  for future developments, and 4  felt that the development of further guidance is premature,  until specific cases of SB  are developed.

3. Although there  41 interventions in total, interventions were made by  17 participants.

11/17 (65%) experts, mostly representing their  governments and regulatory agencies  from Brazil,  Japan, Italy, Canada, the Netherlands, Germany and 2  observer institutions repeated what was the majority view in forum 1: no further guidance is currently required to adequately deal with LMOs developed by SB. On the other hand,  6/17 (35%) participants representing  governments (Mexico, Belarus, Mauritania, New Zealand) and two observers advocated for the development of guidance.

4. Although it is not our task to vote and the final decision will be taken by parties at COP-MOP, as moderator, I feel parties would benefit from understanding how experts involved in the discussions arrived at their respective conclusions and why there is no consensus (65% for no further guidance, just review existing one  vs 35% to develop new guidance ).

On a practical note and to continue with our task, we need to have a working document  to discuss at the next AHTEG meeting in Mexico City (I will call this Doc 4). As invited  moderator,  and in the spirit of transparency, my recommendation to the Secretariat is that Doc 4 should be the submitted document with the most input and support from Forum 2 participants. 
I recommend that Doc 4 should  therefore  be the text originally proposed by Luciana  (# 7985) and  supported by colleagues from the Brazilian government (#7985, #7997) and  reviewed by other participants  ( #7987, #7990, #7986, #8000, #7991, #7995, #8001, #8002, #8003, #8010, and and lastly submitted by Bob Friedman (#8011).

Again, I thank  the Secretariat and all participants wholeheartedly again and wish my colleagues from the RARM AHTEG a very fruitful meeting in Mexico City.

Kind regards,

Maria Mercedes

Dear all,
This post is in the name of my colleague, Margret Engelhard, who was member of the AHTEG Synthetic Biology and whom I´m thank that she gave her opinion on the forum so that I could post it here.
Margret Engelhard:
Many thanks to the Secretariat for preparing this excellent document we are discussing here and to Maria Mercedes to moderate this forum.
I would like to support the document, especially the following topics that might be considered in the discussion about the potential adaptation of current methodologies: Comparative approach, LMOs containing an increased number of modified traits, Potential to alter entire wild populations, Increased accessibility to techniques of synthetic biology.
In addition I would like to suggest that challenges due to the speed of development should be taken into consideration.
In my opinion gene drives clearly belong to synthetic biology and we would like to draw the attention on the fact that the AHTEG Synthetic Biology uses gene drives as one of its examples of synthetic biology. That makes in our view perfectly sense, since gene drives are a good example of the engineering approach that is the central paradigm of synthetic biology.
My comments to the document are enclosed.
With best wishes
Margret Engelhard

Dear Moderator and colleagues,

I thank the moderator's summary, but I would warn again that it is dangerous to count the votings without regarding the nature of questions in debating. Many other colleagues might be busy with other works and were unable to post their opinions at this moment.

The important thing is that I support to develop guidance for the use of synbios on behalf of China in this group. I appreciate and agree to the comments of our colleagues, especially Judy[#8012], Margret [#8014], Ossama [#8007] and Sarah[#8004]. I especially agree that gene drive is one part of synbio [#8014].

For the document that the discussion shall base on is the original document 1 by the secretariat with inputs from all colleages other than a version from a single party.

Best wishes

Wei

Dear colleagues.
The moderator´s task is always difficult and whatever Maria Mercedes does, there will be a group of you unhappy with her final text. I would like to support her strategy of counting opinions (not votes), because this is democratic and also because it reflects not just the mean of two polarized opinions, but the weighted average. If the report does not point to a majority´s opinion (which possible reflects a consensual opinion, not to be confounded with a unanimous opinion, never existent…), it will miss its target: indeed, from the very beginning we knew the opinions were polarized and the forum would be pretty much useless if it did not reflect, at least, a weighted average of opinions.
Kindly
Paulo

I would like to thank Maria for her admirable job in trying to synthesize the various views of the participants in this second online forum.  I think this second forum reinforces the clear conclusion from the first that there is no consensus on the need to provide additional guidance on the LMOs produced through synthetic biology.  Apologies in advance for the instances below where I wrote in all caps to emphasize a point.  I am not shouting but using the only option I could think of to format the text for emphasis.

I have followed Maria's instructions, and have made comments and suggested modifications (in track changes mode) to the text of the background document draft she provided, which I have attached.  I made these comments without reading those of Luciana [#7985], but having read hers, I see several points in common. 

As I have reviewed Maria's initial comments at the start of this second forum, I have reminded myself of her statement that we have embarked on these two discussions because of decision BS-VII/12, which contained, in paragraph 7, an agreement to consider at COP MOP 8 the need for development of further guidance.  Note that the agreement is for PARTIES to consider the need (emphasis mine).  Furthermore, the AHTEG meeting in 2014, a list of topics was developed for which there could be further guidance developed, ON THE BASIS OF THE NEEDS INDICATED BY THE PARTIES (emphasis mine).  Therefore, future activity in the area of future guidance must be directed by a decision of the Parties, not as an ad hoc decision of the AHTEG.  In my view, as a prerequisite for deciding whether guidance on synthetic biology should be developed, the Parties (not the AHTEG), should also conclude which, or even if, organisms produced by tools of synthetic biology, are LMOs.  If they are not LMOs, then the Protocol, and therefore the AHTEG, cannot develop guidance for their risk assessment.  That would be overreaching the scope of the Protocol.  I provide more commentary on this point in the attached document.

That said, I also note Maria's challenge to Identify concrete examples of current and foreseeable LMOs that present novel and specific challenges to the general principles and methodology of risk assessment (I assume she is referring to Annex III of the Protocol).  During the interventions made thus far during this forum, I have seen concrete examples of LMOs that could be considered as produced by tools of synthetic biology, and which have been considered by regulators.  These concrete examples showed that in fact the existing methodology of risk assessment was suitable to conduct risk assessments.  On the other hand, I have seen examples offered of other products of synthetic biology, in order to support the need for additional guidance.  However, these examples are only cases that might be different from what might have been encountered before, but I have not seen specifics on how current risk assessment methodology would be inadequate (not just more complicated or difficult) to address them .  If we are to rationally support a case for additional guidance we should be able to show that the current guidance is inadequate and specifically how that is so.

Thanks to all for another stimulating forum discussion.

Dear participants of the online forum,
Thank you for the opportunity to participate in this interesting and challenging discussion. I have reviewed the posts made so far as well as the edits proposed by some of you on the text of the draft document prepared by the secretariat “Possible considerations during ERA of LMOs developed or created through approaches commonly referred to as “synthetic biology””.
I support the views and edits to the draft document (Doc1 - “Possible considerations during ERA of LMOs developed or created through approaches commonly referred to as “synthetic biology”) put forward in comments #7985, #8001, #8002, #8006, #8010, #8011.
In particular, I think that it is essential that the discussion on considerations related to ERA of LMOs developed with the application of synthetic biology approaches, specific examples are discussed instead of generic categories. Using specific credible examples can help to establish whether or not the current principles of risk assessment and risk management established for LMOs and the principles of ERA would need to be adjusted or not.
Below are specific comments to the draft document “Possible considerations during ERA of LMOs developed or created through approaches commonly referred to as “synthetic biology”.
Title of the document: the current title is using the expression “…LMOs developed or created through approaches commonly referred to as “synthetic biology”. I suggest that the title of the document is edited to: “LMOs developed thought the application of synthetic biology approaches that go beyond the definition of “modern biotechnology” - possible considerations during environmental risk assessment”. This title would allow to  focus the discussion on really specific cases and may help to avoid misunderstanding of what is covered and what is not under this category.
Section on “comparative approach”: I think it is important that the document highlights that the issue of comparative assessment and the use of appropriate comparators is not specific to the LMOs developed with the aid of synthetic biology approaches, but is a general issue that merits a broader review by the AHTEG. It has been discussed in earlier on-line forums that risk assessment does not necessarily need to be performed using a comparator and that alternative approaches may be applicable when necessary.
Section on “LMOs containing an increased number of modified traits”:  I support the proposal to recommend monitoring of the potential developments which would help parties to identify relevant challenging cases that might require adjustments to the current guidance.
Section on “potential to alter entire wild populations”: I support the proposal to avoid  reference to specific technique or current terms (e.g. “gene-drives”), but to focus on the outcome as stated in the title of the section – “to alter entire populations”. I suggest that the word “wild”  be removed as the considerations can be developed with a broader scope.
Section on “increased accessibility to techniques of synthetic biology”: I support the position of those who have pointed out that the issue is not restricted to “synthetic biology” and therefore this section should not be included in the final document, or it should be properly noted that the issue is broader and needs a stand-alone discussion outside of the scope of the current document.
Section on “detection and characterisation of changes a the genome level”: As for the previous section the issue of detection and characterisation is not specific to “synthetic biology” and thus I support the proposed deletion of this section from the document.
With kind regards to all,
Ana

Thank you Maria and colleagues for a lively discussion.

I support Wei Wei's intervention. This isn't a 'democratic' process (we are not deciding, the Parties are) nor is it possible to derive a informative weighted mean because there are any number of factors that influence participation. The forum is for the expression of views by experts. All are qualified to present views and they should be part of compromise text as has always been the case with the development of these documents.

Neither is it a case of being happy or unhappy with the text. Our task was, as I understood it, to provide the MOP with views that represent the variety of views held by experts.

With best regards
Jack

Dear colleagues,
due to workload and other issues I am able to read through all the comments provided to this important discussion only now just before the forum is closing. Due to lack of time I will rely on other colleagues - I fully support the comments made by Judy Carman today and her suggestions to text changes to the Secretariat's document. I thank everybody for their valuable comments: especially those from Wei, Ossama, Galina, Jack and Francisca. Also comments by Valeria, Boet and Nobuyuki have provided useful insight to this discussion and to our different views and understanding of this topic.
I see an urgent need for specific guidance for SynBio to be developed.
Finally - this forum is a discussion forum where we collect expert views on the issue of SynBio. We are discussing the needs of the Parties and clearly some of us see a need to develop further Guidance. And some of us do not. The COP-MOP will make the decision based on the views of all Parties. This forum is not a voting apparatus - but a way to discuss, listen and respect everybody's right to express their views. That is called democracy.
Thank you everybody - I have learnt a lot.
Good night from Helsinki,
Marja

Dear all,

I wish to thank The Secretariat for getting this process started and Maria for her diligent efforts to moderate. I also thank Luciana and the others who provided clear and valuable text suggeations that give better balance to the document the AHTEG will ultimately complete.

Very briefly, I add my voice to the many (majority) of posts that feel guidance on SynBio is premature. Recognizing that it is not our job to make a final recommendation - that is the responsibility of the COP/MOP - I support the approach offered by Maria.  This approach provides factual information to the COP/MOP in a transparent manner.

Thank you.
Tom

As this discussion closes, I would like to express my conclusion which is agreement with Wei Wei.  Considering the policy context which my two earlier posts provided, guidance for synthetic biology is clearly an appropriate focus for the Parties.

Thank you to all for your comments and to the moderator for overseeing this discussion.

Philip L. Bereano
Professor Emeritus

Hello all,

Thank you all for a very lively discussion, especially to those who did the work to provide edits to the text, and of course to Maria for moderating the forum.

I think there is little else I can add regarding further changes to the text provided by Luciana, Valeria, Paulo, and Bob Friedman, largely summarised in [#8011], with which I am in general agreement. As such, I also support Maria’s approach regarding her proposed “Doc4” [#8013].

Kind regards,

Tim

Dear all,
sorry for my late posting.  I was to busy to discuss earlier.
First of all I want to thank Maria Mercedes for moderating and the secretariat for providing the already well sophisticated document. I also want to thank all of you for the interesting discussion that I now benefit from.
Special thanks to Sarah for proving a document that includes most useful extraction of the discussion. I used your document and added my comments in track changes and also Margrets.
I absolutely support Jacks view and again want to point out that in my opinion the most challenging characteristics of LMOs developed or created through synthetic biology is the almost unlimited depth of intervention that can make a comparative approach useless.  I therefore think that risk assessment of such organisms may need a total different approach.
Regards
Birgit

Dear all,
sorry for my late posting.  I was to busy to discuss earlier.
First of all I want to thank Maria Mercedes for moderating and the secretariat for providing the already well sophisticated document. I also want to thank all of you for the interesting discussion that I now benefit from.
Special thanks to Sarah for proving a document that includes most useful extraction of the discussion. I used your document and added my comments in track changes and also Margrets.
I absolutely support Jacks view and again want to point out that in my opinion the most challenging characteristics of LMOs developed or created through synthetic biology is the almost unlimited depth of intervention that can make a comparative approach useless.  I therefore think that risk assessment of such organisms may need a total different approach.
Regards
Birgit

Dear Maria and participants of the online forum,
I would also like to thank Maria for the difficult task of moderating such a diverse range of view in this forum and also apologise for my late posting.
I have attached a version of the document with some changes , using Jim Louter's version (#8001) of the document as a basis as I agree with his comments. My comments are generally in agreement also with  Luciana (#7985). I also support the suggestion by Bob Friedman to include reference to the NIH Guidelines.

Kind regards

Heidi Mitchell

Dear all,
Firstly, I thank Maria for chairing this forum. In her opening remark, and I quote [#7959]:

"Let us please recall that our task was triggered by decision BS-VII/12, in which the COP-MOP mandated the Online Forum and AHTEG to take into account the topics prioritized by the previous AHTEG for the development of further guidance (among which there is a topic on “risk assessment of LMOs developed through synthetic biology”)."
&
"During forum 1   (May 9-23), we had a discussion with the purpose of brainstorming to identify issues that could be of particular relevance in the risk assessment of LMOs developed through synthetic biology."

"I would like to stress that the responsibility to decide whether or not further guidance on RA of LMOs of synthetic biology is needed belongs with the COP-MOP. Our role is to provide the COP-MOP with scientific input to assist the Parties in reaching an informed decision, and the results of our discussion must help guide the outcomes of the COP-MOP."

From Maria's opening remarks, I think Maria makes it very clear that the members to this forum should avoid discussing whether special guidance for Synthetic Biology LMO is needed is out of the scope of this forum, and hence all discussion towards this should be avoided in the first place.

My view on this is that LMO created via Synthetic Biology deserves a special guidance due to the fact that synthetic biology is a very special technique that can pose a challenge in risk assessment and risk management in the context of Cartagena Protocol. I do agree with Judy [#8012], Wei Wei [#7989, 7994, 7996] , Jack [#8012]


While various members of this forum said that no products of synthetic biology have yet been released into the environment, but it is vert clear that synthetic biology is not only being developed but this field has moved on very rapidly. I am of the opinion that the AHTEG should take a more proactive role to develop such guidance, hence I am in agreement of the view expressed by Judy [#8012].


It is interesting to note that some forum contributors have argued that there is no universally accepted Synthetic Biology at this stage, which I agree. But they went on to argue that certain techniques should not be mentioned in the “Doc 1 Secretariat Synbio RARM”. I am struggling to make sense of such argument because if so proper definition of synthetic biology, how could one be so sure which technique should be included or excluded in the said document. I think the examples mentioned eg. Gene drive etc, should be mentioned. Perhaps we can state it clear that the examples given are not an exclusive list. Also, genome editing should be considered.

Overall, I agree with the document titled “Doc 1 Secretariat Synbio RARM” as proposed by the Secretariat as well.

On last point on Maria summary which is handy, but I am of the opinion that it should be a summary without any indication of vote.

Thank you.

Best regards,
Kok Gan Chan
University of Malaya, Malaysia

Dear participants to this online forum,
Firstly, I thank Maria for chairing this forum. In her opening remark, and I quote [#7959]:

"Let us please recall that our task was triggered by decision BS-VII/12, in which the COP-MOP mandated the Online Forum and AHTEG to take into account the topics prioritized by the previous AHTEG for the development of further guidance (among which there is a topic on “risk assessment of LMOs developed through synthetic biology”)."
&
"During forum 1   (May 9-23), we had a discussion with the purpose of brainstorming to identify issues that could be of particular relevance in the risk assessment of LMOs developed through synthetic biology."

"I would like to stress that the responsibility to decide whether or not further guidance on RA of LMOs of synthetic biology is needed belongs with the COP-MOP. Our role is to provide the COP-MOP with scientific input to assist the Parties in reaching an informed decision, and the results of our discussion must help guide the outcomes of the COP-MOP."

From Maria's opening remarks, I think Maria makes it very clear that the members to this forum should avoid discussing whether special guidance for Synthetic Biology LMO is needed is out of the scope of this forum, and hence all discussion towards this should be avoided in the first place.

My view on this is that LMO created via Synthetic Biology deserves a special guidance due to the fact that synthetic biology is a very special technique that can pose a challenge in risk assessment and risk management in the context of Cartagena Protocol. I do agree with Judy [#8012], Wei Wei [#7989, 7994, 7996] , Jack [#8012]


While various members of this forum said that no products of synthetic biology have yet been released into the environment, but it is vert clear that synthetic biology is not only being developed but this field has moved on very rapidly. I am of the opinion that the AHTEG should take a more proactive role to develop such guidance, hence I am in agreement of the view expressed by Judy [#8012].


It is interesting to note that some forum contributors have argued that there is no universally accepted Synthetic Biology at this stage, which I agree. But they went on to argue that certain techniques should not be mentioned in the “Doc 1 Secretariat Synbio RARM”. I am struggling to make sense of such argument because if so proper definition of synthetic biology, how could one be so sure which technique should be included or excluded in the said document. I think the examples mentioned eg. Gene drive etc, should be mentioned. Perhaps we can state it clear that the examples given are not an exclusive list. Also, genome editing should be considered.

Overall, I agree with the document titled “Doc 1 Secretariat Synbio RARM” as proposed by the Secretariat as well.

On last point on Maria summary which is handy, but I am of the opinion that it should be a summary without any indication of vote.

Thank you.

Best regards,
Kok Gan Chan
University of Malaya, Malaysia

My sincere thanks to Maria Merceder for moderating the second round of discussions.
I support the document edits and comments proposed by Luciana P. Ambrozevicius, #7985, Valeria Giovannelli, #7991, Jim Louter, #8001, Boet Glandorf, #8010, Bob Friedman, Heidi Mitchel #8026 and additional comments by Paulo Andrade and Noboyuki Fujita.
I add my opinion to all those colleagues that posted very good arguments considering that SynBio guidance is premature. First let us all agree on a clear definition, after looking on the actual developments within the field.
Kind regards
Sol

I would like to express my sincere thankful to Maria Mercedes for the labor moderating this forum. I agree with the previous colleagues which state that the summary of this forum has to be prepared reflecting all the views and without a “statistics” perspective, because the forum doesn´t has this mandate or objective. And finally the decision will be taken by the COPMOP by way of consensus.
I agree with the document #1 presented by the Secretariat, considering the changes made by Judy Carman. And I also agree with the opinion expressed by Wei, Ossama, Galina, Jack and Francisca. I want to express my complete agreed with the comments made by Dr. Bereano and Marja.
Finally I want to express the importance for the COPMOP to count with all the documents generated along the intersessional period through the agreed process under the CBD procedures aiming to reach compromise and consensus regarding the need of guidance on Synbio risk assessment, considering all the work done by the experts of the AHTEG and the online discussions.

I support the views of Jack Heinemann [8019] and Wei Wei [8015] about not providing statistical breakdown of the replies to this item of discussion. I therefore do not agree with the summary provided by Maria Mercedes Roca [8013]. At the same time, and for the same reasons, I wish to elaborate on why I wanted this change in the document:

“At the beginning of the sixth paragraph, delete: “The views expressed in this document do not reflect consensus or the majority of views. Instead”, on the basis that if several people (including myself), had not been less busy during the previous discussion on synbio, the “majority view” may have been quite different, so that the paragraph now reads “This document attempts to compile views on which considerations could be particularly relevant during the risk assessment of organisms developed through synthetic biology.”

The reason is this: unless a vote is taken, we do not know what the majority view is.  A repeatedly-put view by some participants is not necessarily a majority view of all participants.  People have many reasons for not being able to participate in the time available, including work and family pressures, and it should not be concluded that they have no view on the matter or that they agree with the most vocally-put view.

Dear all,
Thanks again for Maria Mercedes to accept moderating this Forum and the other colleagues to share their point of view.
To save time, I would like to fully support the ideas of Paulo Paes [#7984], [#7999], [#8006] and [#8008]; Luciana Pimenta [#7985] and [#7995]; Nobuyuki Fujita [#7987]; Jim Louter [#8000] and [#8001]; Lúcia de Souza [#7986]; Valeria Giovannelli [#7991]; Gutemberg Sousa [#7993]; Maria Vasconcelos [#7997]; Boet Glandorf [#8010] among other messages that expose the same main points stressed very well in Luciana post [#7995].

I would like to support her comments about the document posted in the message [#7985] too.

Best regards,

Greetings to all,

I am a scientist from Kenya and have been keenly following the discussion and would wish to add my voice. I do agree with those who have stated that the synbio examples are LMOs and risk assessment of LMOs should apply, and treated case-by-case.

Douglas Miano
University of Nairobi, Kenya